Coronary Artery Disease
Conditions
Brief summary
The Redes registry is set up to document the overall clinical performance and costs of the Endeavor Resolute coronary stent in a real life subject population of 450 patients that require a stent in Spain. Primary objectives are the overall cost for patients during initial hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12 months post procedure.
Interventions
DEVICEEndeavor Resolute Stent
Single implantation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is \>18 years old * Subject has agreed to participate in the study by signing the Patient Informed Consent and/or has authorized the collection and disclosure of their personal health information by signing the Patient Data Collection Form. * There is an indication for a drug-eluting stent and a clinical decision to use Endeavor Resolute in all the lesions found. * Subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.
Exclusion criteria
* Subject is a childbearing or breastfeeding female. * Subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media. * Subject has a contraindication to anticoagulants and/or antiplatelets. * Subject's lesion might prevent proper balloon inflation during angioplasty. * Primary or rescue angioplasty. * Subject has one or more drug-eluting stents other than Endeavor Resolute in other lesions. * Intention for elective treatment with other drug-eluting stent other than Endeavor Resolute. * Current medical condition is associated with a life expectancy ≤ 12 months. * Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. Subject can only be enrolled once in this study. * Subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study. * Subject cannot guarantee follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall patient cost | During initial hospitalization and at 12 month follow-up |
| Number of major adverse cardiac events (MACE) | 30 days, 6 months and 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Target Lesion Revascularization (TLR) | 12 Months |
| Procedure, device and lesion success rate | 30 Days |
| Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible) | 12 Months |
Countries
Spain
Outcome results
None listed